NEW YORK, NY – [Insert Current Date/Month, Year] – In a monumental leap for assistive technology and personal independence, Wandercraft, a pioneering force in walking robotics, has announced that its innovative self-balancing personal exoskeleton, Eve, has received clearance from the U.S. Food and Drug Administration (FDA). This landmark approval empowers eligible wheelchair users with spinal cord injuries to experience hands-free upright mobility in their daily lives, moving beyond the traditional confines of rehabilitation settings and into the fabric of ordinary moments that can hold extraordinary meaning.
The FDA clearance for Eve signifies a profound shift, offering a pathway for individuals who previously had limited opportunities to stand and move upright outside of structured clinical environments. Wandercraft’s latest innovation builds upon the robust foundation of its rehabilitation exoskeleton, Atalante X, which is currently deployed in over 150 rehabilitation and research centers worldwide. Eve’s introduction is poised to redefine what’s possible for mobility, fostering greater autonomy and an enhanced quality of life for its users.
The Dawn of Personal Upright Mobility: Main Facts
The core of this groundbreaking news is the FDA’s green light for Eve, an advanced robotic exoskeleton designed for personal use. Unlike its predecessors, Eve’s standout feature is its self-balancing technology, which allows eligible adults with spinal cord injuries (at any level, provided they can operate Eve’s remote control) to walk and perform activities of daily living hands-free. This means users can engage with their environment more naturally, free from the need to use their hands for balance.
The device is specifically intended for use on level indoor surfaces and immediately adjacent open-air areas that are part of a building, such as patios and terraces. Crucially, its operation requires the supervision of a specially trained companion, ensuring safety and optimal utilization. Wandercraft emphasizes that Eve is designed to complement, not replace, the wheelchair, offering an expanded array of opportunities to stand, walk, bend, turn, and use their hands while upright, thereby participating more fully in everyday activities.
Matthieu Masselin, co-founder and CEO of Wandercraft, encapsulated the significance of this achievement, stating, “FDA clearance of Eve marks one of the most important moments in Wandercraft’s history and a significant step for the people, families, clinicians, researchers, and partners who helped make it possible. Together, Atalante X and Eve may offer eligible users a pathway from walking during rehabilitation to upright mobility at home, whether making coffee at the kitchen counter, reaching for a book, or spending time with friends on the patio.” His words highlight the journey from clinical rehabilitation to personal empowerment, emphasizing the practical, life-altering applications of Eve.
A Chronology of Innovation: From Atalante X to Eve’s Emergence
The journey to Eve’s FDA clearance is rooted in years of dedicated research, development, and clinical application, beginning with its precursor, Atalante X. This rehabilitation exoskeleton, known for its dynamic self-balancing capabilities, has been instrumental in helping countless individuals regain mobility and strength in controlled clinical settings. Its widespread adoption in over 150 centers globally provided Wandercraft with invaluable data, insights, and a proven technological platform.
The vision for Eve emerged from the recognition that while rehabilitation exoskeletons were transformative, the true potential lay in extending this freedom beyond the clinic walls. The goal was to create a device that could seamlessly integrate into the daily routines of individuals, enabling them to stand and walk in their homes and immediate outdoor spaces. This required refining the self-balancing technology to be intuitive, robust, and safe for unsupervised (albeit companion-assisted) personal use.
The development process involved rigorous engineering, extensive user feedback, and comprehensive clinical trials. The focus was not just on the mechanics of walking but on the holistic experience of standing upright: reaching for objects, navigating tight spaces, and interacting with the world at eye level. This meticulous approach culminated in a device that addresses both the physical and psychological aspects of mobility, leading to the successful FDA clearance. This clearance represents not merely an approval of a device, but the validation of a new paradigm in assistive robotics – one that prioritizes user independence and integration into everyday life.
Supporting Data and Clinical Evidence: A Foundation of Safety and Efficacy
The FDA clearance for Eve was underpinned by compelling clinical evidence gathered from a three-site clinical trial. This multi-center study involved participants with spinal cord injuries and their specially trained companions, with key contributions from the James J. Peters Department of Veterans Affairs Medical Center in the Bronx, NY, Kessler Foundation in West Orange, NJ, and Walk in New York in New York City, NY. The breadth of these institutions underscores the rigorous and comprehensive nature of the evaluation.
The clinical trial meticulously focused on crucial aspects such as safety, functional performance, the effectiveness of training protocols, and ultimately, the readiness of the device for personal use in real-world scenarios. Participants, representing a diverse range of injury severities, underwent structured training. This was followed by a series of functional, usability, and task-based assessments specifically designed to mirror the demands and environments of everyday life.
The results were overwhelmingly positive. The clinical program robustly demonstrated that both participants and their companions could effectively learn to operate Eve and successfully complete activities relevant to personal use. Participants met key functional and usability endpoints, showcasing significant improvements in walking performance and the ability to perform activities of daily living (ADLs) while upright.
Beyond measurable functional gains, participants reported profound improvements in several qualitative aspects of their lives. These included enhanced health status, improved psychological well-being, increased endurance during daily activities, a reduction in lower-limb spasticity, and better sitting balance. Remarkably, some users also reported improvements in sleep quality and in bladder and bowel function, highlighting the far-reaching systemic benefits of upright mobility.
Gail Forrest, PhD, director of the Tim and Caroline Reynolds Center for Spinal Stimulation at Kessler Foundation, emphasized the significance of these findings: “What makes these findings meaningful is that the technology was evaluated not only on engineering performance but also on how users and companions could safely integrate it into real-world activities. The combination of functional performance, usability, and user-reported outcomes gives this technology substantial clinical relevance.” Her statement underscores the patient-centric approach of the trials, moving beyond mere technical specifications to assess the true impact on users’ lives.
According to the Christopher & Dana Reeve Foundation, over five million people in the United States live with paralysis, with hundreds of thousands affected by spinal cord injuries. For this population, the ability to stand and move upright transcends mere physical action; it represents deeply meaningful experiences that profoundly influence physical health, social interactions, and active participation in daily life. Eve addresses this critical need, offering a tangible solution to reclaim these fundamental aspects of human experience.
Official Responses and User Testimonials: The Human Impact
The official responses to Eve’s clearance resonate with both corporate vision and deeply personal experience. Matthieu Masselin’s statement highlights the collective effort and the future potential of Eve in conjunction with Atalante X, creating a continuum of care from rehabilitation to home use.
Perhaps most compelling are the testimonials from those who have directly experienced Eve’s transformative power. Caroline Laubach, a Wandercraft Test Pilot, shared her journey: “For years, I experienced much of the world while seated. Using Eve transformed ordinary moments in ways I never expected, like having conversations eye-to-eye whether seated or standing, getting a cup from the highest kitchen cabinet, and simply bringing a new type of confidence into my life.” Her words paint a vivid picture of the subtle yet profound changes Eve can bring, from the simple act of eye-level conversation to the boost in self-assurance derived from greater physical autonomy. This "new type of confidence" is a testament to the psychological liberation that accompanies enhanced physical capabilities.
The sentiment shared by Laubach underscores the core philosophy behind Eve: to enable users to interact with their environment and loved ones from a new perspective, literally and figuratively. It’s about more than just walking; it’s about reclaiming agency, dignity, and a sense of belonging in a world often designed for upright individuals.
Broader Implications: Reshaping Healthcare, Robotics, and Accessibility
The FDA clearance of Eve marks a pivotal evolution not just for Wandercraft but for the broader fields of healthcare and robotics. It signifies a critical advancement in bringing highly sophisticated, self-balancing technology out of controlled rehabilitation settings and into personal, everyday environments. This development is supported by a comprehensive care pathway that encompasses clinical assessment, individualized fitting, structured training, assistance with reimbursement, and long-term support, ensuring that the technology is not only available but also accessible and effectively utilized.
Commitment to Access and Reimbursement:
Wandercraft’s dedication to making Eve accessible is evident in its strategic approach to reimbursement and distribution. Recognizing that innovation is only impactful if it can be utilized, the company has made significant investments to facilitate access for qualified users. A crucial factor in this accessibility pathway is Medicare, which has provided a reimbursement route for eligible personal exoskeleton users since 2024 under its Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) program, using billing code K1007.
Wandercraft anticipates that Eve could become eligible for Medicare reimbursement within 60 to 90 days following its commercial launch. Furthermore, the company has concrete plans to broaden patient access through private payers and other funding sources, aiming to make walking at home a reality for as many qualified users as possible. To navigate the complexities of healthcare financing, Wandercraft has established a dedicated group of access specialists who will work closely with users and their care teams. These specialists will assist with claim submissions, help understand coverage requirements, address reimbursement questions, and explore available financing options, thereby removing significant barriers to adoption.
Commercial Launch and Distribution Network:
The commercial launch of Eve in the United States is scheduled for September 17, 2026. This momentous occasion will be officially unveiled at an exclusive event at the Cure healthcare innovation campus in New York City, presented in collaboration with the United Spinal Association, as the organization commemorates its 80th anniversary. This livestreamed program is designed to bring together a diverse audience including individuals living with spinal cord injuries, caregivers, clinicians, researchers, policymakers, and current Eve pilots, to collectively celebrate the transition of self-balancing exoskeleton technology from clinical rehabilitation to personal, home-based use. Interested viewers can register to watch the livestream on September 17 at 6 p.m. ET.
Prior to use, individuals must receive a prescription from a licensed healthcare practitioner. The pathway to taking Eve home involves a comprehensive process: a clinical assessment, an individualized device fitting, and extensive training with a companion. This training, comprising five two-hour sessions that can be completed in as little as one week, covers essential skills such as transfers, remote-controller operation, walking on level surfaces, navigating tight spaces, performing activities of daily living, and crucial safety and emergency procedures.
To ensure a seamless process from initial evaluation to white-glove delivery, Wandercraft has forged strategic partnerships with a growing network of rehabilitation centers, complex rehabilitation technology (CRT) providers, and federal distribution partners, complementing its existing global walk centers.
- Walk US: With its flagship Walk in New York location and a second planned location in Miami, Walk US specializes in neurorehabilitation utilizing Atalante X. It will serve as a pivotal partner for Eve evaluations, training, demonstrations, community education, and preparing users for personal use at home.
- National Seating & Mobility (NSM): As North America’s largest provider of complex rehabilitation technology, NSM will act as Wandercraft’s exclusive CRT distribution partner for Eve. Leveraging its extensive network of over 180 locations across the United States and Canada, NSM will provide crucial support for evaluation, access, delivery, and ongoing service.
- Good Shepherd Rehabilitation: This organization will be the exclusive Eve partner in Pennsylvania’s Lehigh Valley. Through Good Shepherd’s Hyland Center, eligible users and their companions will have the opportunity to learn about and experience the technology, with plans for additional access locations in the future.
- USVetServ: A Service-Disabled Veteran-Owned Small Business, USVetServ will serve as an authorized independent distributor of both Eve and Atalante X for the U.S. Department of Veterans Affairs (VA), including its VA Medical Centers and other VA facilities nationwide. This partnership underscores Wandercraft’s commitment to providing veterans with access to the most advanced assistive technologies.
Collectively, these organizations are establishing the robust clinical, reimbursement, distribution, training, and service infrastructure necessary to translate the FDA clearance into meaningful and widespread access for eligible users, truly making personal upright mobility a reality.
The Broader Horizon: A Future Redefined
The introduction of Eve by Wandercraft transcends the mere launch of a new medical device; it represents a profound societal and technological statement. It signals a future where assistive robotics are not just confined to laboratories or hospitals but are integral components of personal independence, enabling individuals to live fuller, more engaged lives.
The implications are far-reaching. Socially, Eve promotes greater inclusion and challenges conventional perceptions of disability by empowering users to interact with the world from an upright, eye-level perspective. Psychologically, the renewed confidence and ability to perform everyday tasks hands-free can significantly improve mental well-being, reduce feelings of isolation, and foster a greater sense of self-efficacy. Physically, the benefits extend beyond mobility to potentially mitigating secondary health complications often associated with prolonged sitting, such as poor circulation, pressure sores, and bone density loss.
Technologically, Eve’s self-balancing capabilities set a new benchmark for exoskeleton design, pushing the boundaries of what is possible in human-robot interaction and control. This achievement will undoubtedly spur further innovation in the field, leading to even more advanced, intuitive, and versatile assistive devices in the years to come.
While challenges remain, such as continued efforts to broaden reimbursement coverage, ongoing user adaptation, and the eventual evolution of the technology, Eve’s FDA clearance marks an undeniable turning point. It heralds an era where the dream of hands-free upright mobility for individuals with spinal cord injuries is no longer a distant aspiration but a tangible, accessible reality. Wandercraft, through Eve, is not just offering a device; it is offering a gateway to renewed independence, dignity, and a richer participation in the tapestry of daily life.
Learn more at: Wandercraft.eu.
